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Eli Lilly and Company (LLY) Release: Prasugrel Receives Positive Opinion from the European Committee for Medicinal Products for Human Use (CHMP)


12/19/2008 10:45:30 AM

TOKYO and INDIANAPOLIS, Dec. 18 /PRNewswire-FirstCall/ -- Daiichi Sankyo Company, Limited , and Eli Lilly and Company announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has issued a positive opinion recommending approval of prasugrel for the prevention of atherothrombotic events in patients with acute coronary syndromes (ACS) undergoing percutaneous coronary intervention (PCI).

The CHMP positive opinion is now referred for final action to the European Commission, which grants approval in the European Union. The Commission usually makes a decision about whether to approve a new drug candidate within two to three months of CHMP issuing its recommendation. Upon approval, this new oral antiplatelet agent is expected to be marketed throughout the European Union under the proposed brand name EFIENT(TM).

"We are extremely pleased by the CHMP positive recommendation for approval of prasugrel in Europe," said John Alexander, M.D., M.P.H., global head of research and development, Daiichi Sankyo Company, Limited. "Based on the study results and the positive recommendation, we are hopeful that prasugrel will be approved as a new treatment option for patients with ACS undergoing PCI."

The submission package contains data from several trials, including the landmark TRITON-TIMI 38, a head-to-head superiority study that evaluated the safety and efficacy of prasugrel compared with clopidogrel (Plavix(R)/Iscover(R)) in reducing atherothrombotic events (combined endpoint of cardiovascular death, non-fatal heart attack, or non-fatal stroke) in 13,608 patients with acute coronary syndromes undergoing PCI. These data were presented at the American Heart Association Scientific Sessions and simultaneously published online in the New England Journal of Medicine in November 2007.

"Cardiovascular disease remains a significant cause of death and disability worldwide, and this positive opinion is an important step in making this new treatment available to help prevent heart attacks in the ACS patient," said J. Anthony Ware, M.D., Lilly vice president for cardiovascular/acute care.

Cardiovascular disease kills an estimated 17.5 million people worldwide each year, and acute heart attacks and unstable angina, called acute coronary syndromes, affect more than 800,000 people in Europe each year. (1,2)

About prasugrel

Daiichi Sankyo Company, Limited , and Eli Lilly and Company are co-developing prasugrel, an investigational oral antiplatelet agent discovered by Daiichi Sankyo and its Japanese research partner Ube Industries, Ltd., as a potential treatment, initially for patients with acute coronary syndromes who are undergoing PCI. Prasugrel works by inhibiting platelet activation and subsequent aggregation by blocking the P2Y12 adenosine diphosphate (ADP) receptor on the platelet surface. Antiplatelet agents prevent platelets from clumping or sticking together, which can result in clogged arteries and may lead to heart attack or stroke. Lilly, on behalf of its alliance partner, Daiichi Sankyo, submitted a Marketing Authorization Application for prasugrel to the European Medicines Agency in February 2008.

About Acute Coronary Syndromes

Acute coronary syndromes, which is comprised of heart attacks and unstable angina (chest pain), affects nearly 1.5 million people in the United States annually.(3) ACS, a fatal consequence of coronary heart disease, is the single most common cause of death in the European Union, accounting for more than 741,000 deaths in the EU each year.(4) Heart attack is a major manifestation of coronary heart disease, which occurs when the arteries become narrowed or clogged by cholesterol and fat deposits and cannot supply enough blood to the heart. In some cases, a blood clot may partially or totally block the blood supply to the heart resulting in ACS.(5) Many ACS patients undergo PCI, which usually includes a stent placement.

About Daiichi Sankyo

A global pharma innovator, Daiichi Sankyo Co., Ltd., was established in 2005 through the merger of two leading Japanese pharmaceutical companies. This integration created a more robust organization that allows for continuous development of novel drugs that enrich the quality of life for patients around the world. A central focus of Daiichi Sankyo's research and development are thrombotic disorders, malignant neoplasm, diabetes mellitus, and autoimmune disorders. Equally important to the company are hypertension, hyperlipidemia or atherosclerosis and bacterial infections. For more information, visit www.daiichisankyo.com.

About Eli Lilly and Company

Lilly, a leading innovation-driven corporation, is developing a growing portfolio of first-in-class and best-in-class pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Ind., Lilly provides answers - through medicines and information - for some of the world's most urgent medical needs.

This press release contains certain forward-looking statements about the potential of the investigational compound prasugrel (CS-747, LY640315) and reflects Daiichi Sankyo's and Lilly's current beliefs. However, as with any pharmaceutical compound under development, there are substantial risks and uncertainties in the process of development and regulatory review. There is no guarantee that the compound will receive regulatory approval, that the regulatory approval will be for the indication(s) anticipated by the companies, or that later studies and patient experience will be consistent with study findings to date. There is also no guarantee that the compound will prove to be commercially successful. For further discussion of these and other risks and uncertainties, see Lilly's filing with the United States Securities and Exchange Commission and Daiichi Sankyo's filings with the Tokyo Stock Exchange. Daiichi Sankyo and Lilly undertake no duty to update forward- looking statements.

Plavix(R)/Iscover(R) are registered trademarks of sanofi-aventis.

P-LLY

(2) Bertrand M, CURE study investigator and Professor of Cardiology, University of Lille, France. Sanofi-Synthelabo and Bristol-Myers Squibb Company press release, "CPMP Recommends Granting Marketing Authorization In the European Union For Plavix(R)/Iscover(R) (clopidogrel) for the Treatment of Acute Coronary Syndrome with Non ST Segment Elevation," June 27, 2002.

(3) American Heart Association. Heart Disease and Stroke Statistics - 2008 Update. http://www.americanheart.org/downloadable/heart/1200082005246HS_Stats%202008.f inal.pdf. Accessed December 9, 2008.

(4) British Heart Foundation Health Promotion Research Group. European Cardiovascular Disease Statistics 2008, http://www.ehnheart.org/files/statistics%202008%20web-161229A.pdf, Accessed December 9, 2008.

(5) WebMD Medical Reference in Collaboration with the Cleveland Clinic. Heart Disease: Coronary Artery Disease. http://www.webmd.com/heart-disease/guide/heart-disease-coronary-artery- disease. Accessed December 9, 2008.

(Logo: http://www.newscom.com/cgi-bin/prnh/20061120/DSLLOGO )


CONTACT: Carole Copeland (OUS), Eli Lilly and Company, +1-317-277-3661
(office), +1-317-610-6196 (cell), or Tammy Hull (U.S.A.), Eli Lilly and
Company, +1-317-651-9116 (office), +1-317-614-5132 (cell); or Kim Wix,
Daiichi Sankyo (U.S.A.), +1-973-695-8338 (office), +1-908-656-5447 (cell),
or Shigemichi Kondo, Daiichi Sankyo (Tokyo), 81-3-6225-1126 (office)


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